Method and apparatus for monitoring implantable device for urinary continence

ABSTRACT

One or more sensors are incorporated onto one or more of an implantable device and a surgical tool used for placement and/or adjustment of the implantable device. The implantable device includes an adjustable membrane element for controllable coaptation of a body lumen, such as coaptation of a urethra as treatment for urinary incontinence. In various embodiments, the one or more sensors can be configured to detect information indicative of at least one of a shape of the adjustable membrane element, a position of the adjustable membrane element relative to the body lumen, or a shape of the body lumen.

CLAIM OF PRIORITY

This application is a continuation of U.S. patent application Ser. No.16/450,246, filed Jun. 24, 2019, which claims the benefit of priorityunder 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Ser. No.62/805,503, entitled “METHOD AND APPARATUS FOR MONITORING URINARYINCONTINENCE IMPLANTABLE DEVICE”, filed on Feb. 14, 2019, each of whichare herein incorporated by reference in their entirety.

TECHNICAL FIELD

This document relates generally to implantable medical devices and moreparticularly to a method and system for monitoring placement and/oradjustment of an implantable devices for treating urinary incontinence.

BACKGROUND

An example of an implantable device for treating urinary incontinenceincludes an adjustable membrane element, such as a balloon, connected toa rear port with a conduit. The implantable device can be implanted in apatient with the adjustable membrane element placed adjacent to thepatient's urethra and the rear port placed underneath the patient's skinby a minimally invasive surgery. The adjustable membrane element can beadjusted during and after the surgery by injecting fluid into the rearport or extracting fluid from the rear port percutaneously using aneedle. In an exemplary treatment, two of such implantable devices areplaced in the patient such that the two adjustable membrane elementsprovide pressure and support at the patient's bladder neck to protectagainst accidental leaking of urine during sneeze, cough, or physicalactivity. The efficacy of this treatment depends on proper placement inthe patient and adjustment of the adjustable membrane element after theplacement.

SUMMARY

One or more sensors are incorporated onto one or more of an implantabledevice and a surgical tool used for placement and/or adjustment of theimplantable device. The implantable device includes an adjustablemembrane element for controllable coaptation of a body lumen, such ascoaptation of a urethra as treatment for urinary incontinence. Invarious embodiments, the one or more sensors can be configured to detectinformation indicative of at least one of a shape of the adjustablemembrane element, a position of the adjustable membrane element relativeto the body lumen, or a shape of the body lumen.

In various embodiments, an implantable device for controllablecoaptation of a body lumen can include an adjustable membrane elementand an elongate conduit. The adjustable membrane element can include acontinuous wall having an inner surface defining a chamber. The elongateconduit can include a peripheral surface connected to and sealed to theadjustable membrane element, a rear end, a front end, and a lumenextending longitudinally in the elongate conduit from a first opening atthe rear end to a second opening in fluid communication with the chamberof the implantable device for adjustably expanding or contracting theadjustable membrane element by applied flowable material introducedthrough the first opening. One or more sensors can be incorporated intothe implantable device and/or a sensor probe for monitoring positioningof the implantable device, adjustment of the implantable device, and/orstate of coaptation of the body lumen. In one embodiment, one or moresensors are incorporated onto at least one of the adjustable membraneelement or the elongate conduit of the implantable device. In anotherembodiment, a sensor probe includes a front end into which a sensorincorporated. In one embodiment, the lumen of the elongate conduit isconfigured to accommodate a portion of the sensor probe including itsfront end. In another embodiment, the implantable device includesanother lumen extending longitudinally in the elongate conduit andhaving an inlet configured to receive a portion of the sensor probe anda closed end to stop the sensor probe or an outlet configured to allow aportion of the sensor probe including its front end to exit. In variousembodiments, the one or more sensors can include one or more opticalsensors, such as cameras or borescopes, and/or one or more ultrasonictransducers for producing an ultrasonic image.

This summary is an overview of some of the teachings of the presentapplication and not intended to be an exclusive or exhaustive treatmentof the present subject matter. Further details about the present subjectmatter are found in the detailed description and appended claims. Thescope of the present invention is defined by appended claims and theirlegal equivalents.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an implantable device and a syringesource for providing a flowable material to an adjustable membraneelement of the implantable device, according to an embodiment of thepresent subject matter.

FIG. 2 is a longitudinal cross-sectional view of the implantable deviceshown in FIG. 1 , according to an embodiment of the present subjectmatter.

FIG. 3 is a cross-sectional view taken along line 3-3 of FIG. 2 ,according to an embodiment of the present subject matter.

FIG. 4 illustrates a guide probe inserted into body tissue to an implantlocation adjacent a body lumen of a patient prior to insertion of theimplantable device, according to an embodiment of the present subjectmatter.

FIG. 5 shows the implantable device placed over the guide probe andpartially advanced to the desired location with the adjustable membraneelement being deflated, according to an embodiment of the presentsubject matter.

FIG. 6 shows the implanted device after being expanded at the desiredlocation in the body tissue of the patient to displace body tissuetoward the body lumen for causing adjustable restriction of the bodylumen, according to an embodiment of the present subject matter.

FIG. 7 is a cross-sectional view taken along line 7-7 of FIG. 6 ,according to an embodiment of the present subject matter.

FIG. 8 shows the implantable device after being inserted with its rearport underneath the skin of a patient, according to an embodiment of thepresent subject matter,

FIG. 9 is a schematic of another implantable device, according to anembodiment of the present subject matter.

FIG. 10 is a schematic of another implantable device, according to anembodiment of the present subject matter.

FIG. 11 is a top view showing approximate target sites of placement ofimplantable devices to improve coaptation of a urethra, according to anembodiment of present subject matter,

FIG. 12 is a view along the length of the urethra in the area ofimplantation showing approximate target sites of placement ofimplantable devices to improve coaptation of a urethra, according to anembodiment of present subject matter.

FIG. 13 is an illustration of an implantable device and a sensor probe,according to an embodiment of present subject matter.

FIG. 14 is an illustration of a portion of a sensor probe, according toan embodiment of present subject matter.

FIG. 15 is an illustration of a front end of a sensor probe, accordingto an embodiment of present subject matter.

FIG. 16 is a cross-sectional view of a portion of a front end of animplantable device, according to an embodiment of present subjectmatter.

FIG. 17 is a cross-sectional view of a portion of a front end of animplantable device, according to an embodiment of present subjectmatter.

FIG. 18 is an illustration of an implantable device with one or moresensors, according to an embodiment of present subject matter,

FIG. 19 is an illustration of an implantable device kit, according to anembodiment of present subject matter.

FIG. 20 is an illustration of coaptation of a body lumen using animplantable device, according to an embodiment of present subjectmatter.

FIG. 21 is an illustration of coaptation of a body lumen using twoimplantable devices, according to an embodiment of present subjectmatter.

FIG. 22 is an image showing two implantable devices implanted in apatient adjacent to a body lumen for coaptation of that body lumen,according to an embodiment of present subject matter.

FIG. 23 is an illustration of a single-lumen implantable device and asensor probe, according to an embodiment of present subject matter.

DETAILED DESCRIPTION

The following detailed description of the present subject matter refersto subject matter in the accompanying drawings which show, by way ofillustration, specific aspects and embodiments in which the presentsubject matter may be practiced. These embodiments are described insufficient detail to enable those skilled in the art to practice thepresent subject matter. References to “an”, “one”, or “various”embodiments in this disclosure are not necessarily to the sameembodiment, and such references contemplate more than one embodiment.The following detailed description is demonstrative and not to be takenin a limiting sense. The scope of the present subject matter is definedby the appended claims, along with the full scope of legal equivalentsto which such claims are entitled.

This document discusses, among other things, a system and method formonitoring placement and/or adjustment of an implantable device fortreating urinary incontinence. The implantable device can include, forexample, an adjustable membrane element connected to a rear port with aconduit that has a lumen providing for fluid communication between achamber of the adjustable membrane element and an interior cavity of therear port. Various structural elements of the implantable device (e.g.,the implantable device 110 shown in FIG. 1 ) discussed in this documentmay each be referred to by various terms. The “adjustable membraneelement” (e.g., the adjustable membrane element 112 shown in FIG. 1 )can also be referred to as, for example, an adjustable element, anexpandable element, an expandable membrane element, a forward expandablemembrane element, a balloon, or an adjustable balloon. The “conduit”(e.g., the conduit 114 shown in FIG. 1 ) can also be referred to as, forexample, a central conduit element, a device conduit, a connectingconduit, a connecting conduit tube, or a tubular elongate body. The“rear port” (e.g., the rear port 116 shown in FIG. 1 ) can also bereferred to as, for example, a rearward port portion or a rear portelement. The “lumen” (e.g., the first lumen 215 and the second lumen 217shown in FIG. 2 ) can also be referred to as, for example, a passageway,an inner passageway, or an interior passageway.

In an example, the implantable device includes an adjustable balloonconnected to a port with a conduit. The balloon is placed adjacent theurethra to exert non-circumferential compression upon the urethral wall.The effectiveness of the therapy depends on proper positioning of theballoon in a patient's body, such as in retropubic space (resulting froma radical prostatectomy) near the urethra-vesical anastomosis above theurogenital diaphragm in close proximity to the urethral walls. When twoballoons (e.g., of two implantable devices) are used, their preferredpositioning is usually symmetrical and lateral with respect to theurethra. Fluoroscopy or transrectal ultrasonography can be used tovisually monitor the positioning of the balloon(s) during theimplantation of the implantable device(s). Fluoroscopy has become astandard technique, but exposes the patient to radiation and provides atwo-dimensional view that presents viewing difficulties under somecircumstances. For examples, when the patient is on operation table, thefluoroscopic image does not show the location of the balloons on theanterior-posterior plane, and therefore does not show whether theballoons are properly positioned to exert compression upon the urethralwall. Transrectal ultrasonography (FRITS) can provide for better viewing(e.g., the location of the balloons on the anterior-posterior plane) butrequires the surgeon to be familiar with this imaging technique, Duringan implantable process, implantable device(s) are initially placed inthe patient with the balloon(s) positioned in the target space(s). Theballoon(s) can be left slightly inflated to allow for encapsulation (bythe patient's tissue) without migration from the target space(s). Afterthe encapsulation, the patient will go through one or more adjustmentprocedures during which the balloon(s) are adjusted to obtain andmaintain urinary continence without causing undesirable obstruction.

The present subject matter uses one or more sensors incorporated ontothe implantable device and/or a surgical tool for implanting theimplantable device to monitor the placement and/or adjustment of theimplantable device(s). This monitoring technique avoids use offluoroscopy or transrectal ultrasonography and their disadvantages suchas exposure to x-ray or rectal insertion of ultrasonic probe. In oneembodiment, the one or more sensors include one or more ultrasonictransducers on the implantable device and/or the surgical tool allow forultrasonic imaging to be used to monitor the placement and adjustment ofthe balloon(s) during device implantation. The ultrasonic sensor(s) onthe implantable device can further allow for post-operative adjustmentof the balloon(s).

In various embodiments, the present subject matter provides sensingmeans for monitoring, for example, location of each balloon and amountof inflation (expansion) of each balloon. In various embodiments, thesensing means can also be used for monitoring various states of theurethra that can indicate an amount of compression resulting from adegree of expansion of the balloon, such as excessive compressionresulting from over-inflation of the balloon, adequate compression(target of the treatment), and insufficient compression resulting fromunder-inflation of the balloon. The target of the treatment is toprovide the patient with continence without undesirable obstruction, andthis requires the right amount of coaptation of the urethra resultingfrom placing the balloon(s) in the right position(s) and giving eachballoon the right amount of inflation. The present subject matter allowsfor determination of the right position and right amount of inflationfor each balloon.

FIGS. 1-10 illustrate various embodiments of an implantable medicaldevice and a surgical tool. The surgical tool includes an elongate bodyand can be used as a base device onto which the one or more sensors canbe incorporated. The implantable medical device can be used with thesurgical tool including the sensor(s), or can be used as a base deviceonto which the one or more sensors can be incorporated. The variousembodiments of the implantable device and the surgical tool areillustrated in FIGS. 1-10 and discussed below by way of example, and notby way of restriction. These examples as well as additional examples ofthe implantable device and the surgical tool are discussed in U.S. Pat.Nos. 5,964,806, 6,045,498, 6,419,624, 6,579,224, and 8,926,494, allassigned to UroMedica, Inc., which are incorporated by reference hereinin their entireties. FIGS. 11-23 illustrate various embodiments of theone or more sensors incorporated onto an implantable device and/or asurgical tool such as those discussed in the document.

According to the present subject matter as shown by FIG. 1 , there isprovided an elongate implantable device 110, which includes anadjustable membrane element 112 shown in its full expanded size, and isattached pressure-tightly to an elongate conduit 114, which is connectedto a rear port 116 communicating with the expandable element 112 througha first lumen 215 (see FIG. 2 ). The conduit 114 has a pointed forwardend 114A which extends slightly beyond the expandable element 112. Asyringe 120 including a hollow needle 121 and a rear axially-movableplunger 122 is provided for adjustably injecting a suitable flowablematerial into the implantable device 110 through the rear port 116 toexpand the adjustable membrane element 112.

As further shown in FIGS. 2 and 3 , the conduit 114 contains twoelongate lumens or passageways. The first lumen 215 provides an internalpassage by which the flowable material is directed from a cavity 216A inthe rear port 116 to expand the adjustable membrane element 112. Theconduit 114 is attached integrally to the rear port 116 at its rearwardend. A second lumen 217 extends from a front opening 117A to a rearwardopening 117B and serves to receive an elongate guide probe (see FIG. 4 )and effect delivery of the implantable device 110 to a desired locationin the body tissue of a patient.

An important feature of the implantable device 110 having the firstlumen 215 includes a first opening port 215A located in cavity 216A ofthe rear port 116 between an elastic septum 218 and the conduit 114 andis connected to the first lumen 215, so that a flowable material can beinfused therethrough, and a second port 215B serves to direct theworking fluid to the adjustable membrane element 112. During adjustmentof the volume of the membrane fluid provided from a hollow needle 121 ofsyringe 120, is infused through the septum 218 and continues through theconduit 114 connected to the adjustable membrane element 112. The rearport 116 preferably has a diameter greater than conduit 114 toaccommodate the cavity 216A and the septum 218, which is retainedsecurely by a clamp ring 119.

The entire implantable device 110 including the adjustable membraneelement 112 is formed of a biocompatible material such as silicone orpolyurethane elastomer, and the conduit 114 and the rear port 116 may beformed as a unitary construction. Optionally, the adjustable membraneelement 112, the rear port 116, and the conduit 114 can be molded as onepiece. As shown in FIG. 2 , the adjustable membrane element 112 isadhered at 213 to conduit tube 114 at its forward end by a suitableadhesive material.

The implantable device and assembly according to the present subjectmatter can include three main members. The first member provided is anelongate guide in the form of a stiff solid elongate guide probe 424(see FIG. 4 ) configured for delivery of the implantable device 110 tothe desired site in the body tissue of a patient as generally shown byFIGS. 4 and 5 . Alternatively, the elongate guide member can be in theform of a flexible guidewire which has been initially delivered into thebody tissue through a separate hollow stiff probe that has been insertedto the desired location in the body tissue. The second member of theassembly is the implantable device 110 which includes the adjustablemembrane element 112, the conduit 114 containing the two lumens 215 and217, and the rear port 116. During its implantation, the implantabledevice 110 is guided to a pre-determined location adjacent a body lumenin a patient's body after the elongate solid guide probe 424 is firstsurgically inserted into the body tissue of the patient to establish aninitial pathway. The lumen forward end opening 117A of the implantabledevice 110 is then disposed over the rear end of the guide probe 424 toguide the implantable device 110 and deliver the adjustable membraneelement 112 (in its contracted shape) to the pre-determined location inthe body tissue adjacent to the lumen which is to be adjustablyrestricted. The diameter of the second lumen 217 is made slightly largerthan that of the guide probe 424 to permit the implantable device 110 toslide easily over the probe member.

During the implantation of the implantable device 110, a physician canfirst make a small incision in the skin 430 of the patient near a bodylumen 432 that needs to be restricted, and then by visualization meanssuch as fluoroscopy or ultrasonic imaging, the solid guide probe 424 isdirected to the desired location, depending upon the anatomy of thepatient. Thereafter, the opening 117A of the second lumen 117 of theconduit 114 with the adjustable membrane element 112 in its initialdeflated or contracted condition, is slid over the rear end 424A of theguide probe 424. The guide probe 424 slides through the second lumen 217of the conduit 114 and exits at the rearward opening 117B. Asillustrated in FIG. 2 , the opening 117B is between the adjustablemembrane element 112 and the rear port 116, However, it may beadvantageous to locate the opening 117B close to the adjustable membraneelement 112 or, alternatively, to have the second lumen 217 extendthrough the rear port 116.

If desired, a mark 533 can be provided on the guide probe 424 which whenaligned with a feature on the implantable device 110 such as the rearport 116 can assure that the implantable device 110 is appropriatelyplaced at the correct depth in the patient's body tissue 430. It may benecessary to provide the conduit 114 in multiple lengths to facilitateplacement of the septum 218 near the patient's skin. Alternatively, aneffective length of the conduit 114 can be made adjustable by it havinga helical shape similar to that of a coiled spring.

After the implantable device 110 has been advanced over guide probe 424so that the contracted adjustable membrane element 112 is in the desiredposition adjacent to the body lumen 432, the body lumen 432 may berestricted to a desired degree by piercing septum 218 with the needle121 of syringe 120 and injecting a flowable material through the firstlumen 215 into the adjustable membrane element 112. The physician candetermine the desired degree of restriction of body lumen 432 by meanssuch as infusing fluid through the body lumen past the restriction andmeasuring the back pressure.

As illustrated by FIGS. 1 and 6 , the source of flowable material isusually a syringe 120 with a hollow needle used to pierce the elasticseptum 218. However, alternate fluid containers with means for making areversible connection to the implantable device 110 could be used. Theflowable material may be, for example, a saline solution, a flowablegel, or a slurry of particles in a liquid carrier. It may beadvantageous to make the flowable material radiopaque so that the degreeof membrane inflation may be viewed by x-ray.

An alternative method of delivery of the implantable device 110 can beto first withdraw the guide probe 24 from the body tissue and theninflate the adjustable membrane element 112. A further alternative wouldbe to first place the implantable device 110 over the solid guide probe424 outside the body and then insert them both into the body tissue as aunit. To facilitate this latter procedure, it may be desirable thatthere be some friction between the solid guide probe 424 and the secondlumen 217 in the conduit 114.

After the implantable device 110 has been properly positioned with theadjustable membrane element 112 located near the body lumen 432 and theseptum 218 in the rear port 116 located near the skin 430, the device isinjected with a flowable material from the syringe 120. The expandablemember can be inflated to a certain extent and then deflated to anextent suitable for encapsulation of the expandable member by bodytissue. The guide probe 24 is then withdrawn from the device, leavingthe slightly expanded membrane element in the body tissue. Then the skinincision 431 is closed over the port 116 by means such as a suture 834as shown in FIG. 8 .

The present subject matter provides the implantable device 110 withadjustability of the membrane expansion post-operatively. Thisadjustability is effected because the septum 218 is located remote fromthe adjustable membrane element 112 but near and under the patient'sskin. The port and septum is located by, for instance, manual palpationof the skin region and the needle of the syringe is inserted through theskin and septum to add or remove material from the expandable member,thus increasing or decreasing the restriction of the body lumen.

To assure proper sealing of the septum 218, it is placed in compressionwithin a cavity 216A by providing a tight metal ring 119 that surroundsthe rear port 116 and is smaller in diameter than the port. When theneedle 121 of the syringe 120 is withdrawn from the septum 218 afterexpansion or adjustment of the adjustable membrane element 112, there ispositive sealing around the perimeter of the septum 218.

FIGS. 4-8 generally illustrate the method or procedure for properlyimplanting the implantable device 110 into the body tissue of a patient.As shown by FIG. 4 , a physician, after locating the body lumen such asa urethra of the patient, makes a small incision 431 and inserts theguide probe 424 in the body tissue to a desired location adjacent thebody lumen 432. This procedure is usually carried out under a localanesthetic with visual guidance, for instance under fluoroscopy, by thephysician. Next, the physician takes the implantable device 110 andplaces it over the guide probe 424 through the second lumen 217 as shownin FIGS. 1 and 2 , The guide probe 424 enters the rear opening 117B andexits the forward opening 117A. The implantable device 110, with theconduit 114 being sufficiently flexible, is advanced along the guideprobe 424 into the body tissue.

After the desired location within the body tissue has been reached, asuitable flowable material is introduced into the implantable device 110from a source such as the syringe 120 having hollow needle 121 insertedthrough septum 218 to at least partially expand the adjustable membraneelement 112, as shown by FIG. 6 . Next, the guide probe 424 is removedand the adjustable membrane element 112 is expanded further to thedesired enlarged size for restriction of the body lumen 432. The syringe120 is removed from the implantable device 110, after which the desiredsize of the adjustable membrane element 112 is maintained by the elasticseptum 218. Next, the patient's incision at 431 is surgically closedover the port 116 and septum 218 by sutures at 834.

FIG. 9 is an illustration of an implantable device kit 940, showing across-sectional view, according to one embodiment of the present subjectmatter. The implantable device kit 940 includes an implantable device910 having an adjustable membrane element 912 and an elongate conduit914, where the conduit 914 includes at least a first lumen 915 whichextends longitudinally in the conduit 914 from a first opening 915A at arear end (also referred to as a proximal end) 962 to a second opening915B, and where the implantable device 910 is shown positioned within achannel 944 of a sheath 946.

The implantable device kit 940 further includes a rear port 916, wherethe rear port 916 is coupled to the rear end 962 of the conduit 914. Inone embodiment, the rear port 916 is coupled to the rear end 962 of theelongate body 914 using chemical adhesives, or alternatively, usingsonic welding techniques as are known in the art. In an additionalembodiment, the rear port 916 and rear end 962 are formed together in apolymer molding process, such as liquid injection molding, as are knownin the art.

The rear port 916 includes a cavity 916A, Where the cavity 916A is influid communication with the first opening 915A of the conduit 914. Inone embodiment, the rear port 916 also includes an elastic septum 918through which the cavity 916A is accessed, where the elastic septum 918is a sealable after repeated pierces, for example, with a needle. In oneembodiment, the elastic septum 918 is retained in the rear port 916 by aclamp ring 919 located around the rear port 916. In one embodiment, theclamp ring 919 is made of a biocompatible material, such as, forexample, titanium. In one embodiment, the elastic septum 918 is made ofa biocompatible material, such as, for example, silicone orpolyurethane. The rear port 916 has an outer diameter defined by anouter surface 954 of the rear port 916. In one embodiment, the rear port916 has an outer diameter of 1 to 15 millimeters, with 4.5 millimetersbeing a specific example.

In one embodiment, the outer surface of the rear port 916 and theadjustable membrane element 912 are of a size (e.g., a diameter) that issmaller than an inner size (e.g., a diameter) of the channel 944 toallow the implantable device 910 to be moved longitudinally through thechannel 944 of the sheath 946. In an alternative embodiment, the rearport 916 is constructed of at least one material flexible enough toallow the size of the rear port 916 in its relaxed state to becompressed to a size sufficiently small so that the implantable device910 can be moved longitudinally through the channel 944 of the sheath946. In various embodiments, the conduit 914 has a stiffness sufficientto allow force applied at the rear end of its tubular elongate body tomove the implantable device 910 at least partially through the channel944 of the sheath 946. In one embodiment, the stiffness of the conduit914 is determined based on the type of material used in constructing itstubular elongate body. Alternatively, support elements can be added tothe tubular elongate body. For example, a metal coil can be placedlongitudinally within the tubular elongate body to increase thestiffness of the tubular elongate body.

Once the implantable device 910 is positioned within a body, theadjustable membrane element 912 is inflated by releasably connecting aflowable material source to the rear port 916. In one embodiment, theflowable material source includes a syringe with a non-coring needle,where the needle is inserted through the elastic septum 918. A measuredsupply of fluid volume can be introduced into the implantable device910, and the adjustable membrane element 912 expands or contracts due toa volume of flowable material introduced into the cavity 916A of therear port 916 from the flowable material source. The adjustable membraneelement 912 is then used to at least partially and adjustably restrictthe body lumen. Fluids suitable for infusing into the prosthesisinclude, but are not limited to, sterile saline solutions, polymer gelssuch as silicone gels or hydrogels of polyvinylpyrrolidone, polyethyleneglycol, or carboxy methyl cellulose for example, high viscosity liquidssuch as hyaluronic acid, dextran, polyacrylic acid, polyvinyl alcohol,or a radio-opaque fluid for example. Once the adjustable membraneelement 912 has been inflated, the needle is withdrawn from the septumof the rear port 916. In an additional embodiment, a detectable marker970 is imbedded in the continuous wall of the adjustable membraneelement 912. The detectable marker 970 allows the adjustable membraneelement 912 to be located within the tissues of a patient using anynumber of visualization techniques which employ electromagnetic energyas a means of locating objects within the body. In one embodiment, thedetectable marker 970 is constructed of tantalum and the visualizationtechniques used to visualize the adjustable membrane element 912 arex-ray or fluoroscopy as are known in the art.

In an additional embodiment, a detectable marker is imbedded in theimplantable device 910. For example, the detectable marker 970 islocated at a front end (also referred to as a distal end) 960 (e.g., thetip) of the conduit 914. Alternatively, the detectable marker can belocated in the continuous wall of the adjustable membrane element 912,The detectable marker 970 allows the front end 960, or the adjustablemembrane element 912, to be located within the tissues of a patientusing any number of visualization techniques which employelectromagnetic energy as a means of locating objects within the body.In one embodiment, the detectable marker 970 is constructed of tantalumand the visualization techniques used to visualize the front end 960, orthe adjustable membrane element 912, are x-ray or fluoroscopy as areknown in the art. In an additional embodiment, the sheath could alsohave a detectable marker, where the marker could be incorporated into,or on, the wall of the sheath. Alternatively, the entire sheath could beconstructed to be radio-opaque.

FIG. 10 is an illustration of an additional embodiment of an implantabledevice 1010 according to the present subject matter. The implantabledevice 1010 includes an adjustable membrane element 1012 and a conduit1014. The conduit 1014 has a front end 1060. In one embodiment, theperipheral surface of the conduit 1014 is connected to and sealed to theadjustable membrane element 1012. In one embodiment, the adjustablemembrane element 1012 includes a continuous wall having an inner surfacedefining a chamber.

The conduit 1014 includes a first lumen 1015 and a second lumen 1017. Inone embodiment, the first lumen 1015 extends longitudinally in theconduit 1014 from a first opening 1015A to one or more second openings1015B (e.g., two openings as shown in FIG. 10 ). The second opening(s)1015B is in fluid communication with the chamber of adjustable membraneelement 1012 for adjustably expanding or contracting the adjustablemembrane element 1012 by flowable material introduced through the firstopening 1015A.

The second lumen 1017 extends longitudinally along the conduit 1014 froman inlet 1017B to a closed end 1017A at the front end 1060. In oneembodiment, the second lumen 1017 and the inlet 1017B are each ofsufficient diameter to receive a push rod that can be used to advancethe implantable device 1010 in the tissue.

The implantable device 1010 further includes a rear port 1016, which iscoupled to the rear end of the conduit 1014. In one embodiment, the rearport 1016 is similar to the rear port 916 and includes a cavity 1016Aand an elastic septum 1018. The cavity 1016A coupled to and in fluidcommunication with the first lumen 1015 at the first opening 1015A. Theelastic septum 1018 allows for excess to the cavity 1016A using aneedle, for introducing and/or withdrawing fluid to expand and/orextract the adjustable membrane element 1012.

FIG. 11 is a top view of a bladder 1101 and a urethra 1102 showingapproximate target sites of placement of the implantable devices 1110 toimprove coaptation of a urethra, according to an embodiment of presentsubject matter. The implantable devices 1110 can present any embodimentof the implantable device as discussed in this document (with theexpandable membrane element or the adjustable membrane element shown inthe figure to illustrate its location), including but not limited to theimplantable device 110, the implantable device 910, the implantabledevice 1010, or an implantable device including various combinations offeatures of the implantable devices 110, 910, and 1010. A Cartesiancoordinate system with X-, Y-, and Z-axes is shown in FIGS. 11-21 (withtwo of the X-, Y-, and Z-axes seen in each of these figures) as areference for exemplary orientations of structures illustrated in thesefigures. The orientation of the Z-axis is along the direction of theurethra 1002 in the approximate location of implantation. The locationis near the bladder neck and urethral vesical anastomosis in the case ofradical prostatectomy or further down the urethra at the apex of theprostate after Trans-Urethral Resection of the Prostate (TURP).

FIG. 12 is a view along the length of the urethra 1102 in the area ofimplantation (or along the y-axis) showing approximate target sites ofplacement of the implantable devices 1110 to improve coaptation of aurethra, according to an embodiment of present subject matter. Thepresent subject can assist in the proper placement of the implantabledevices 1110 during implantation into the patient and/or adjustment ofthe implantable devices 1110 after the implantation. In particular, theaccurate placement of the implantable devices 1110 along the Y-axis(sagittal view) is facilitated by the applications of the presentsubject matter.

FIG. 13 is an illustration of an implantable device kit 1320, includingan implantable device 1310 and a sensor probe 1324, according to anembodiment of present subject matter. The implantable device 1310 andthe sensor probe 1324 can be provided as a device kit, which may alsoinclude other accessories. The implantable device 1310 can be used tocoapt a lumen in a body, and can include an adjustable membrane element1312, an elongate the conduit 1314, and a rear port 1316. The adjustablemembrane element 1312 is configured to coapt the lumen and includes acontinuous wall having an inner surface defining a chamber. The conduit1314 has a rear end 1315, a front end 1313 coupled to the adjustablemembrane element 1312, a peripheral surface connected to and sealed tothe adjustable membrane element 1312 near the front end 1313, and anlumen (not shown in FIG. 13 ) extending longitudinally in the conduit1314 from a first opening at the rear end 1315 to a second opening at ornear the front end 1313 in fluid communication with the chamber. Therear port 1316 is coupled to the rear end 1315, and includes a cavity influid communication with the first opening of the first lumen and anelastic septum allowing access to the cavity by a needle. In someembodiments, the rear port 1316 is releasably coupled to the rear end ofthe conduit 1314. The implantable devices 1310 can present anyembodiment of the implantable device as discussed in this document,including but not limited to the implantable device 110, the implantabledevice 910, the implantable device 1010, or an implantable deviceincluding various combinations of features of the implantable devices110, 910, and 1010.

The sensor probe 1324 has an elongate body 1326 having a rear end 1327 afront end 1325, and one or more sensors 1328 incorporated onto theelongate body 1326. In various embodiments, the sensor probe 1324 can beconstructed by incorporating the sensor(s) 1328 into any surgical toolthat is used during the implantation and/or adjustment of theimplantable device 1310 and has an elongate body. Examples of such asurgical tool include a push rod (e.g., push rod 1450) and a guide probe(or guide rod or guide wire, e.g., guide probe 424). In one embodiment,as illustrated in FIG. 13 , one sensor 1328 at the front end 1325 isillustrated. In another embodiment, as illustrated in FIG. 14 , whichshows a portion of a sensor probe 1424 according to an embodiment ofpresent subject matter, a plurality of sensors 1328 is distributed overat least a portion of the elongate body 1326.

In various embodiments, the sensor(s) 1328 can be rotated by rotatingthe elongate body 1326, such as by rotating the rear end 1327. Theelongate body 1326 can include a sensor connection circuit 1330, such asat the rear end 1327. Conductors 1329 extend within the elongate body1326 to provide connections between sensor(s) 1328 and sensor connectioncircuit 1330. In one embodiment, sensor connection circuit 1330 includesa connector for connection to an external system that processes signalssensed by sensor(s) 1328. In another embodiment, sensor connectioncircuit 1330 includes a telemetry circuit and a battery such that it cancommunicate with the external system wirelessly. The telemetry circuitcan perform the wireless communication using, for example,electromagnetic, magnetic, acoustic, or optical telemetry.

In various embodiments, sensor(s) 1328 can include one or moreultrasonic transducers each to convert an electrical input signal toultrasound, transmit the ultrasound, receive a reflected ultrasound(echo of the transmitted ultrasound), and convert the received reflectedultrasound to an electrical image signal. The external system canreceive the electrical image signal and produce an ultrasonic imagebased on the electrical image signal. The one or more ultrasonictransducers can each include a piezoelectric transducer or a capacitivetransducer, and each have an ultrasonic beam direction and an ultrasonicbeam angle.

In various embodiments, sensor(s) 1328 can include one or more opticalsensors. The one or more optical sensors can each include acharge-coupled device (CCD) image sensor or an active pixel sensor (APS,also known as complementary, metal-oxide-semiconductor (CMOS) imagesensor) to convert captured image to an electrical image signal. Theexternal system can receive the electrical image signal and produce avisual image based on the electrical image signal.

In various embodiments, the lumen of the implantable device 1310 that isin fluid communication with the chamber is also configured to receivethe sensor probe 1324, which is used as a push rod (e.g., as illustratedin FIG. 9 ). The end of lumen at the front end 1313 is configured toreceive a force applied through the sensor probe 1324 to move theimplantable device 1310. The lumen includes a closed end near the frontend 1313. The closed end has sufficient strength and hardness to receivethe front end 1325 of the sensor probe 1324 and transfers force appliedat the rear end 1327 of the sensor probe to the implantable device 1310.

In various other embodiments, a first lumen of the implantable device1310 is in fluid communication with the chamber for adjusting the volumeof the chamber, and the implantable device 1310 includes a second lumenextending longitudinally within at least a portion of the conduit 1314and configured to receive the sensor probe 1324 (e.g., as illustrated inFIGS. 2, 3, 5, and 10 ). The second lumen includes an inlet at or nearthe rear end 1315 of the conduit 1314 and an outlet at or near the frontend 1313 of the conduit 1314. The front end 1313 is configured toreceive a force applied through the sensor probe 1324 to move theimplantable device 1310.

In one embodiment, the second lumen includes a closed end near the frontend 1313 of the conduit 1314. This closed end has sufficient strengthand hardness to receive the front end 1325 of the sensor probe 1324 andtransfers force applied at the rear end 1327 of the sensor probe 1324 tothe implantable device 1310. FIG. 16 is a cross-sectional view of aportion of the front end 1613 of an elongate conduit 1614 showing aclosed end of the first or second interior passage way that isconfigured to receive the force applied through the sensor probe 1324 tomove the implantable device 1310, according to an embodiment of presentsubject matter. The front end 1613 can represent an example of the frontend 1313. In one embodiment, the front end 1613 includes a sensor window1635 to provide for transparency to the signals to be sensed. Forexample, ultrasound transparent material can be used for the sensorwindow 1635. The sensor window 1635 can be configured for a specifiedoverall ultrasonic beam angle, up to 360 degrees (i.e., the sensorwindow has a length equal to the circumference of the second lumen).

In another embodiment, the sensor probe 1324 includes a sharp tipsuitable for penetrating tissue, as in the example illustrated in FIG.10 . FIG. 15 is an illustration showing a front end 1525 of a sensorprobe 1524, according to an embodiment of present subject matter. Thesensor probe 1524 can represent an example of the sensor probe 1324 andincludes a sharp tip 1531 at the front end 1525. The second lumenincludes an outlet near the front end 1313 of the conduit 1314. Theoutlet allowing a portion of the sensor probe 1524 including the sharptip 1531 to protrude from the conduit 1314. FIG. 17 is a cross-sectionalview of a portion of a front end 1713 of an elongate conduit 1714,according to an embodiment of present subject matter. The front end 1713can represent an example of the front end 1313. The second lumenincludes a first shoulder 1736 and the sensor probe 1524 includes asecond shoulder 1532 configured to abut the first shoulder 1736 to allowtransfer of force applied at a rear end 1327 of the sensor probe 1324 tothe implantable device 1310. In one embodiment, as illustrated in FIGS.15 and 17 , the first shoulder 1736 is formed by a change in diameter ofthe second lumen, and the second shoulder 1532 is formed by a change indiameter of the sensor probe 1524. Sensor(s) 1328 can be incorporated onto an elongate body 1526 of the sensor probe 1524 at the front end 1525such that both the sharp tip 1531 and the sensor(s) 1328 can protrudefrom the conduit 1314 of implantable device 1310.

FIG. 18 is an illustration of an implantable device 1810 with one ormore sensors, according to an embodiment of present subject matter.Implantable device 1810 includes the implantable device 1310 asdiscussed above and one or more sensors 1828 incorporated onto theimplantable device 1310. Implantable device 1810 further includes asensor connection circuit 1840, such as at the rear end 1315, andconductors 1841 that extend within the elongate body 1314 to provideconnections between sensor(s) 1828 and sensor connection circuit 1840.In the illustrated embodiment, implantable device 1810 includes sixsensors 1828 at a distal connection between the adjustable membraneelement 1312 and the conduit 1314, a rare connection between theadjustable membrane element 1312 and the conduit 1314, and along amidline of the adjustable membrane element 1312 that is perpendicular tothe conduit (i.e., perpendicular to the Z-axis). In various embodiments,any number of sensors incorporated onto any location on the implantabledevice 1810. For example, one or more sensors 1828 can be incorporatedonto the conduit 1314 (e.g., at or adjacent the front end 1313, at oradjacent the distal connection between the adjustable membrane element1312 and the conduit 1314, and/or at or adjacent the rear connectionbetween the adjustable membrane element 1312 and the conduit 1314)and/or the adjustable membrane element 1312 (e.g., on a midline of theadjustable membrane element 1312 that is perpendicular to the conduit1314, adjacent the distal connection between the adjustable membraneelement 1312 and the conduit 1314, and/or adjacent the rear connectionbetween the adjustable membrane element 1312 and the conduit 1314.

In various embodiments, sensor(s) 1828 can include one or moreultrasonic transducers each to convert an electrical input signal toultrasound, transmit the ultrasound, receive a reflected ultrasound(echo of the transmitted ultrasound), and convert the received reflectedultrasound to an electrical image signal. An external system can receivethe electrical image signal and produce an ultrasonic image based on theelectrical image signal. The one or more ultrasonic transducers can eachinclude a piezoelectric transducer or a capacitive transducer, and eachhave an ultrasonic beam direction and an ultrasonic beam angle. Aplurality of ultrasonic transducers can be arranged on the implantabledevice 1810 provide a specified overall ultrasonic beam angle (e.g., 90,180, 270, or 360 degrees).

In various embodiments, sensor(s) 1828 can include one or more opticalsensors. The one or more optical sensors can each include a CCD imagesensor or an APS to convert captured image to an electrical imagesignal. The external system can receive the electrical image signal andproduce a visual image based on the electrical image signal.

In various embodiments, sensor(s) 1828 can include one or more of anytype that can sense signals useful in assisting the placement andadjustment of the implantable device 1810, such as pressure sensors andstrain gauges.

The sensor connection circuit 1840 can be within the rear port 1316 andprovide for access to the one or more sensors 1828 via the rear port1316. In one embodiment, the implantable deice 1810 can communicate withthe external system using a wired connection. The sensor connectioncircuit 1840 includes a connector. The external system includes apercutaneous connector to pierce the elastic septum of the rear port1316 and mate the connector in the rear port 1316, In anotherembodiment, the implantable deice 1810 can communicate with the externalsystem wirelessly. The sensor connection circuit 1840 includes atelemetry circuit and a battery or inductive power receiver. Thetelemetry circuit can transmit power to the implantable device 1810 andreceive the sensed signals from the implantable device 1810.

FIG. 19 is an illustration of an implantable device kit 1920, accordingto an embodiment of present subject matter. Implantable device kitincludes at least an implantable device 1810 and a sensor probe 1324, asillustrated in FIG. 19 , and can also include other tools or accessoriesused for implantation of the implantable device 1810. One or moresensors selected from sensor(s) 1828 and sensor(s) 1328 can be used toprovide for monitoring of the implantable device 1810 duringimplantation and/or adjustment. For various purposes and circumstances,a user can use one or more sensors of implantable device 1810 only, oneor more sensors of sensor probe 1324 only, or sensors of bothimplantable device 1810 and sensor probe 1324 for the monitoring.

FIG. 20 is an illustration of coaptation of the body lumen 1102 using animplantable device 2010 and a probe 2024, according to an embodiment ofpresent subject matter. Examples of implantable device 2010 include, butare not limited to, any implantable device (with or without the one ormore sensors) discussed in this document, such as implantable devices110, 910, 1010, 1310 and 1810. Examples of the probe 2024 include, butare not limited to, any probes (with or without the one or more sensors)discussed in this document, such as the guide probe 424, the push rod1450, and the sensor probes 1324, 1424, and 1524, A sensor 2028represents any one or more sensors that are incorporated ontoimplantable device 2010 and/or probe 2024. In one embodiment, sensor2028 provides an image such as the one shown in FIG. 22 for guiding theplacement of the implantable device 2010 adjacent the lumen 1102 (e.g.,the urethra) for coaptation of the lumen, and/or allows fordetermination of whether the body lumen is coapted to a desirableextent.

FIG. 21 is an illustration of coaptation of the body lumen 1102 usingtwo implantable devices 2010 and two probes 2024, according to anembodiment of present subject matter. FIG. 22 shows an example of animage of this therapy. When the body lumen (e.g., the urethra) isproperly coapted, flattening of the adjustable membrane elements 1312 ofeach implantable device facing the lumen is observed. In variousembodiments, sensors 2028 can be used to provide images and/or otherinformation indicative of the position of each of the implantabledevices 2010, the degree of flattening of the adjustable membraneelements 1312, and/or the shape of the body lumen, thereby providing forguidance in placing and/or adjusting the implantable devices 2010, Theshape of the body lumen can indicate a degree of the coaptation of thebody lumen. In various embodiments, sensor 2028 placed in each of theimplantable device 2010 can detect information indicative of a shape ofthe adjustable membrane element 1312 of the same implantable device, aposition of the adjustable membrane element 1312 of the same implantabledevice (e.g., relative to the body lumen 1102), a shape of theadjustable membrane element 1312 of the other implantable device 2010, aposition of the adjustable membrane element 1312 of the otherimplantable device 2010 (e.g., relative to the body lumen 1102), and/ora shape of the body lumen 1102. In various embodiments, sensor 2028placed in the implantable device 2010 can detect information indicativeof a shape and/or a position of another implantable device, or a portionthereof, that is present in the tissue near the implantable device 2010,

FIG. 23 is an illustration of an implantable device kit 2320, includinga single-lumen implantable device 2310 and a sensor probe 2324,according to an embodiment of present subject matter. The implantabledevice kit 2320 can represent an example of implantable device kit 1320,with the implantable device 2310 used for coaptation of a urethra andthe sensor probe 2324 used for detecting one or more indications of astate or degree of the coaptation of the urethra and adjusting thevolume in an adjustable membrane element 2312 of implantable device 2310for optimal efficacy in treating urinary incontinence without creatingobstruction of the urethra. The implantable device 2310 includes a frontend 2360, a rear port 2316, and an elongate conduit 2314 connectedbetween the front end 2360 and the rear port 2316. The adjustablemembrane element 2312 is affixed onto the conduit 2314 near the frontend 2360 and includes a continuous wall having an inner surface defininga chamber. A lumen 2315 extends longitudinally within the conduit 2314and is in fluid communication with the chamber of the adjustablemembrane element 2312 at a distal opening 2315B and with a cavity 2316Aof the rear port 2316 at rear opening 2315A. In the illustratedembodiment, the sensor probe 2324 is a 3-in-1 device that can also beused as (1) a sensing device including a sensor 2328 at a front end ofthe sensor probe 2324, (2) a push rod to advance the implantable device2310 in tissue by applying force against a closed front end of the lumen2315 at the front end 2360, and (3) an hallow needle that includes alumen 2365 through which a fluid can be introduced and withdrawn forinflating and deflating the adjustable membrane element 2312,respectively, through the distal opening 2315B of the lumen 2315. Thelumen 2315 is configured to accommodate the front portion of the sensorprobe 2324 with the front end of the sensor probe 2324 reach the closedfront end of the lumen 2315. As shown in FIG. 23 , pressure from theurethra may flatten a side of the adjustable membrane element 2312 whenthe adjustable membrane element 2312 is placed adjacent the urethra andinflated. The sensor 2328 can allow for observation of such flattening,which indicates the amount of pressure that can be adjusted for theoptical efficacy of treating the urinary incontinence.

As shown in FIG. 23 , the adjustable membrane element 2312 is inflatedto provide urethral coaptation and has a flattened portion where itmeets resistance to expansion from the urethra. The implantable device2310 includes a radiopaque marker 2370 at the front end 2360. Theradiopaque marker 2370 also serves as a stop for the sensing probe 2324to assure that it is in the right position for sensing. The stop alsoserves as a stop for a push rod (e.g., the sensor probe 2324 used as thepush rod) for placement of the implantable device 2310 in an initialimplantation procedure. When the sensor probe 2324 is used as the pushrod, the placement and/or initial adjustment of the implantable device2310 can be guided using the sensor 2328 to observe the coaptation ofthe urethra. The rear port 2316 includes a self-sealing septum 2318 toallow access to the lumen 2315 by the sensor probe 2324 (as well asother push rod or push-wire, if used). The front end of the sensor probe2324 has a sharp tip for piercing through the septum 2318. The advantageof a single lumen implantable device includes providing morecross-sectional area to accommodate the sensor 2328 in the conduit 2314of a given diameter.

In the illustrated embodiment, the sensor 2328 is an optical sensor forvisually observing the flattening of the adjustable membrane element2312 against the urethra as a proxy for actual visualization ofcoaptation within the urethra. In another embodiment, the sensor 2328 isan ultrasonic sensor. In addition to directly observing the coaptationof the urethra, if the ultrasonic sensor transmits an ultrasound havingsufficient depth of penetration within the tissue, it may also allow forvisualization of the adjustable membrane element 2312 in relation toanatomic structures such as the bladder neck and the rectum. Suchvisualization can be used to aid placement of the adjustable membraneelement 2312 during the implantation of the implantable device 2310. Invarious embodiments, the sensor 2328 can include any type of sensor thatallows for detection of the flattening of the adjustable membraneelement 2312 and/or visualization of the adjustable membrane element2312 in the tissue in relation to various anatomic structures.

In the illustrated embodiment, the sensor 2328 (i.e., the opticalsensor) includes an optical sensing element 2361 for observing theflattening of the adjustable membrane element 2312 with a CCD or CMOSchip 2362 that obtains a radial view with the aid of a mirror 2363. Thechip 2362 is powered, and data acquired by the sensor 2328 are returned,via filament 2364. The filament 2364 can also be used to power a lightsource such as an LED to aid in visualization (which is unnecessary ifthe chip 2362 is an infrared CCD or CMOS chip). The sensor probe 2324can be rotated about its longitudinal axis within the lumen 2315 to scancircumferentially to find the point of maximum coaptation where theadjustable membrane element 2312 is flattened. Rotating the sensor probe2324 can also aid in passing it through curves in the conduit 2314,especial when the rear port 2316 is routed into the scrotum or labia. Atleast for this reason, the sensor probe 2324 is provided with a certainamount of flexibility. In one embodiment, the sensor probe 2324 with theoptical sensor 2328 is equipped with a wide-angle lens to allow forviewing the entire internal surface of the adjustable membrane element2312 such that circumferential scanning would not be necessary.

In another embodiment, the sensor probe 2324 can include a borescope foroptical visualization with a fiber optic bundle extending through thesensor probe. A light source within the sensor probe 2324 is unnecessarybecause the fibers can also be used to transmit light from a lightsource externally connected to the sensor probe. The fiber optic bundlemay have a diameter that is substantially smaller when compared to thesize of a CCD or CMOS chip, thereby reducing the diameter of the sensorprobe 2324 and hence the diameter of the conduit 2314 and rear port2316. This allows for a reduction of the overall size of the implantabledevice 2310 and the overall size of the sensor probe 2328. A smallerdiameter for the sensor probe 2324 is desirable because it has to passthrough the skin of the scrotum or labia to reach the rear port 2316 ofthe implantable device 2310 after it is implanted in the patient.Additionally, the fiber optic implementation of the sensor probe 2324may reduce the cost of production when compared to the optical sensorimplementation with CCD or CMOS chip, thereby improving affordability ofmaking the sensor probe 2324 as a disposable device.

This application is intended to cover adaptations or variations of thepresent subject matter. It is to be understood that the abovedescription is intended to be illustrative, and not restrictive. Thescope of the present subject matter should be determined with referenceto the appended claims, along with the full scope of legal equivalentsto which such claims are entitled.

What is claimed is:
 1. An implantable device kit for controllable coaptation of a body lumen in tissue of a living body, comprising: two implantable devices each including: an adjustable membrane element including a continuous wall having an inner surface defining a chamber, the adjustable membrane element configured to coapt the body lumen; an elongate conduit including a conduit peripheral surface, a conduit rear end, a conduit front end, and a conduit lumen, the conduit peripheral surface connected to and sealed to the adjustable membrane element at or near the conduit front end, the conduit lumen having a first opening at the conduit rear end, a second opening in fluid communication with the chamber; and a closed end at or near the conduit front end; and a rear port connected to the conduit rear end and including a cavity in fluid communication with the first opening of the conduit lumen; and two sensor probes each configured to be partially placed in one implantable device of the two implantable devices and each including: a probe front end having a sharp tip and configured to enter the conduit lumen of the one implantable device by piercing through the rear port of the one implantable device and reach the closed end of the conduit lumen; and a sensor configured to detect information indicative of a degree of the coaptation of the body lumen, wherein the two implantable devices are each configured to be completely enclosed within the tissue by implantation with the adjustable membrane element adjacent the body lumen.
 2. The implantable device kit of claim 1, wherein the two sensor probes each comprise a probe lumen configured to be in fluid communication with the chamber of the adjustable membrane element of the one implantable device when the probe front end is within the conduit lumen of the one implantable device at the closed end of the conduit lumen, to allow for inflation of the adjustable membrane element by introducing a fluid into the chamber through the probe lumen, and to allow for deflation of the adjustable membrane element by withdrawing the fluid from the chamber through the probe lumen.
 3. The implantable device kit of claim 2, wherein the two sensor probes are each configured for use as a push rod for advancing the one implantable device in the tissue during an implantation of the one implantable device.
 4. The implantable device kit of claim 3, wherein the sensor comprises an optical sensor.
 5. The implantable device kit of claim 4, wherein the optical sensor comprises a camera.
 6. The implantable device kit of claim 4, wherein the optical sensor comprises a fiber optic borescope.
 7. The implantable device kit of claim 1, wherein the sensor comprises an ultrasonic sensor.
 8. The implantable device kit of claim 1, wherein the conduit front end comprises a sensor window providing for transparency to a signal to be received by the sensor when the sensor is placed in the conduit lumen.
 9. An implantable device kit for controllable coaptation of a body lumen in tissue of a living body, comprising: two sensor probes each including a probe front end and a sensor incorporated onto the probe front end and configured to detect information indicative of a degree of the coaptation of the body lumen; and two implantable devices each including: an adjustable membrane element including a continuous wall having an inner surface defining a chamber, the adjustable membrane element configured to coapt the body lumen; an elongate conduit including a conduit peripheral surface, a conduit rear end, a conduit front end, a first conduit lumen, and a second conduit lumen, the conduit peripheral surface connected to and sealed to the adjustable membrane element at or near the conduit front end, the first conduit lumen having a first opening at the conduit rear end and a second opening in fluid communication with the chamber, the second conduit lumen having an inlet configured to receive a portion of the sensor probe including the probe front end and an closed end at or near the conduit front end and is configured to allow the probe front to advance to the closed end; and a rear port connected to the conduit rear end and including a cavity in fluid communication with the first opening of the first conduit, wherein the two implantable devices are each configured to be completely enclosed within the tissue by implantation with the adjustable membrane element adjacent the body lumen.
 10. The implantable device kit of claim 9, wherein the two sensor probes are each configured for use as a push rod for advancing one implantable device in the tissue during an implantation of that implantable device.
 11. The implantable device kit of claim 9, wherein the sensor comprises an optical sensor.
 12. The implantable device kit of claim 11, wherein the optical sensor comprises a camera.
 13. The implantable device kit of claim 11, wherein the optical sensor comprises a fiber optic borescope.
 14. The implantable device kit of claim 9, wherein the sensor comprises an ultrasonic sensor.
 15. The implantable device kit of claim 9, wherein the conduit front end comprises a sensor window providing for transparency to a signal to be received by the sensor when the sensor is placed in the second conduit lumen.
 16. The implantable device kit of claim 9, wherein the second conduit lumen comprises an outlet at or near the conduit front end allowing the probe front end including the sensor to protrude from the elongate conduit.
 17. A method for controllable coaptation of a body lumen in tissue of a living body, comprising: providing controllable coaptation of the body lumen using two implantable devices each including: an adjustable membrane element including a continuous wall having an inner surface defining a chamber; and an elongate conduit including a conduit peripheral surface connected to and sealed to the adjustable membrane element, a conduit rear end, a conduit front end, and a conduit lumen extending longitudinally in the conduit from a first opening at the rear end to a second opening in fluid communication with the chamber of the implantable device for adjustably expanding or contracting the adjustable membrane element by a flowable material introduced through the first opening, wherein the two implantable devices are each configured to be completely enclosed within the tissue by implantation with the adjustable membrane element adjacent the body lumen; and providing two sensor probes each configured to be partially placed in one implantable device of the two implantable devices and including a sensor configured to detect information indicative of a degree of the coaptation of the body lumen when the sensor probe is partially placed in the one implantable device after the one implantable device is completely enclosed within the tissue.
 18. The method of claim 17, wherein providing the two sensor probes comprises providing two sensor probes each including a portion configured to be placed in the conduit lumen with the sensor positioned in the conduit lumen at or near the conduit front end.
 19. The method of claim 17, further comprising providing each device of the two implantable devices with an additional conduit lumen extending longitudinally in the conduit from an inlet configured to receive a portion of one probe of the two sensor probes to a front end at or near the conduit front end.
 20. The method of claim 17, further comprising detecting at least one of a shape of the adjustable membrane element or a position of the adjustable membrane element of each implantable device of the two implantable devices when at least one sensor probe of the two sensor probes is partially placed in one implantable device of the two implantable devices. 